The following data is part of a premarket notification filed by Pharmaquest Corp. with the FDA for Adult Flex Float W/heater.
Device ID | K812681 |
510k Number | K812681 |
Device Name: | ADULT FLEX FLOAT W/HEATER |
Classification | Mattress, Water, Temperature Regulated |
Applicant | PHARMAQUEST CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | FOH |
CFR Regulation Number | 880.5560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-09-22 |
Decision Date | 1981-10-08 |